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BISOGAMMA ® 10, 10 mg film-coated tablets Bisoprolol fumarate Read the package leaflet carefully before you start taking this medicine because it contains important information for you. • Keep the leaflet. You may need to read it again. • If you have any further questions, ask your doctor or pharmacist. • This medicine has been prescribed for you personally. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you notice any side effects, tell your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4 What is in this leaflet 1. What Bisogamma 10 is and what it is used for 2. What you need to know before you take Bisogamma 10 3. How to take Bisogamma 10 4. Possible side effects 5. How to store Bisogamma 10 6. Contents of the pack and other information 1. What Bisogamma 10 is and what it is used for The active substance of Bisogamma 10 is bisoprolol. Bisoprolol belongs to a group of medicines known as beta-blockers. These medicines affect the body's response to certain nerve impulses, especially those in the heart, as a result of which bisoprolol slows down the heart rate and the heart pumps blood more effectively to the body. At the same time, the heart's consumption of blood and oxygen is reduced. Bisogamma 10 is used to treat the following conditions - High blood pressure (hypertension) - Chest pain caused by impaired blood circulation in the coronary arteries (coronary heart disease, angina pectoris). 2. What you need to know before taking Bisogamma 10 Do not take Bisogamma 10 if: - you are allergic to bisoprolol fumarate or any of the other ingredients of this medicine (listed in section 6). - you have acute heart muscle weakness (heart failure) or worsening of heart failure (decompensation) that requires intravenous therapy with heart-strengthening agents. - you have cardiogenic shock, which is an acute, serious heart condition causing a drop in blood pressure and circulatory failure. - you have a high degree of conduction disorder from the atria to the ventricles (second or third degree atrioventricular block) that is not equipped with a pacemaker. - you have sick sinus syndrome (sinus node dysfunction syndrome). - you have a conduction disorder between the sinus node and the atria (sinoatrial block) - you have a very slow heart rate (pulse less than 50 beats/min) before starting treatment; - you have very low blood pressure (systolic blood pressure below 90mmHg) - you have severe bronchial asthma; - you have a late stage of vascular disease that impairs blood circulation in the arms and legs (peripheral arterial occlusive disease). - you have spasms of the blood vessels in your hands and feet (Raynaud's syndrome), which causes loss of sensation, burning, and color changes in the fingers and toes in the cold. - you have an untreated tumor of the adrenal gland (pheochromocytoma). - you have excess acidity of the blood related to metabolism (metabolic acidosis). If you suspect that any of the above conditions apply to you, consult your doctor before taking this medicine. Warnings and precautions Before taking Bisogamma 10, talk to your doctor or pharmacist if: - you have diabetes with widely fluctuating blood sugar levels; symptoms of severe hypoglycemia (rapid heart rate, palpitations, and sweating) may be masked; - you are on a strict fasting diet. - during desensitisation therapy (e.g. prevention of allergic rhinitis). Like other beta-receptor blockers, bisoprolol may increase sensitivity to allergens and the severity of anaphylactic reactions, i.e. acute generalized allergic reactions. If allergic reactions occur, inform your doctor that you are taking Bisogamma 10 so that they can take this into account when treating the allergic reaction. - you have a low degree of conduction disorder from the atria to the ventricles (1st degree atrioventricular block). - you have impaired blood circulation to the heart due to spasmodic narrowing of the coronary arteries (Prinzmetal's angina). - you have a vascular disease that causes limited blood supply to the limbs (symptoms may worsen, especially at the beginning of treatment). In patients with a history of psoriasis, treatment with a beta-adrenoceptor blocker (e.g. Bisogamma 10) is initiated after careful assessment of the benefit and risk of the preparation. Symptoms of hyperthyroidism (thyrotoxicosis) may be masked during treatment with bisoprolol. In patients with a tumor of the adrenal medulla (pheochromocytoma), the preparation is administered only after prior administration of alpha-adrenoceptor blockers. Your doctor will prescribe a special treatment (additional preparations) if you have any of the above conditions. If you are going to have general anesthesia, the anesthesiologist should be informed about treatment with beta-blockers. In this case, it is recommended to continue treatment, as it can have a beneficial effect on possible heart rhythm and circulatory disorders that may occur during surgery. If beta-blocker treatment is discontinued before surgery if necessary, it should be done gradually and treatment should be completed approximately 48 hours before anesthesia. In case of chronic lung disease or bronchial spasms (bronchial asthma) that may be associated with symptoms, bronchodilator treatment should be administered in parallel. Sometimes there may be an increase in airway resistance in asthmatic patients, which requires an increase in the dose of beta-2-sympathomimetics. Other medicines and Bisogamma 10 Tell your doctor or pharmacist if you are taking/using, have taken/used or plan to take/use any other medicines. Simultaneous use with the following medicines is not recommended: With heart medications and calcium antagonists of the verapamil and diltiazem type, a sharp drop in blood pressure, slowed conduction from the atria to the ventricles, and a decrease in heart muscle contractility have been observed. Intravenous use of calcium antagonists of the verapamil type can primarily cause a sharp drop in blood pressure (hypotension) and conduction disorders from the atria to the ventricles (atrioventricular block). Concomitant use with centrally acting antihypertensive drugs such as clonidine and others (e.g., methyldopa, moxonidine, and reserpine) can lead to slowing of the heart rate or a decrease in stroke volume and vasodilation. In addition, abrupt discontinuation of clonidine may lead to excessive increase in blood pressure. Bisogamma 10 may be taken with the following medicines only in exceptional cases and with great caution: Concomitant use with calcium antagonists of the dihydropyridine type (e.g., nifedipine) can cause a sharp drop in blood pressure, and in patients with heart muscle weakness, it can further weaken the heart muscles. The cardiodepressive effect of Bisogamma 10 and medicines used to treat heart arrhythmias (antiarrhythmics such as quinidine, disopyramide, lidocaine, phenytoin, flecainide, propafenone, amiodarone) on cardiac conduction time and contractility may be enhanced. Central nervous system medications (parasympathomimetics) can prolong cardiac conduction time and increase the risk of bradycardia. Topical beta-blockers (e.g., eye drops for glaucoma treatment) may enhance the effect of Bisogamma 10. Concomitant use of Bisogamma 10 with insulin or other blood sugar-lowering drugs (oral antidiabetics) may increase their effect. Warning signs of low blood sugar (hypoglycemia) - especially rapid heart rate (tachycardia) - may be masked or less pronounced. Concomitant administration of Bisogamma 10 and anesthetics may lead to an increased drop in blood pressure. Counter-regulatory mechanisms, e.g., increased heart rate (reflex tachycardia), may be weakened. Beta-blockers reduce the risk of arrhythmias during anesthesia and artificial respiration. The anesthesiologist should be informed about treatment with Bisogamma 10. Concomitant use of Bisogamma 10 and cardiac glycosides (digitalis) may lead to further slowing of the heart rate or impaired cardiac conduction. Analgesics and anti-inflammatory drugs (non-steroidal anti-inflammatory drugs (NSAIDs) such as acetylsalicylic acid) may weaken the blood pressure-lowering effect of Bisogamma 10. If Bisogamma 10 is used with certain emergency medications (sympathomimetics such as orciprenaline, dobutamine, adrenaline, noradrenaline), the effect of both substances may be weakened. An increase in blood pressure, as well as worsening of blood circulation in the limbs (intermittent claudication), may occur. The antihypertensive effect of Bisogamma 10 may be enhanced by drugs for depression or mental disorders, as well as epilepsy and sleeping pills (tricyclic antidepressants, phenothiazines, barbiturates). Use Bisogamma 10 with caution when taking the following medicines: Taking Bisogamma with the antimalarial drug mefloquine increases the risk of bradycardia. Concomitant use with antidepressants (monoamine oxidase inhibitors, except MAO-B inhibitors) can affect blood pressure regulation (there is a risk of blood pressure drop or increase). The use of Bisogamma 10 may show positive results in doping control. Taking Bisogamma 10 with food, drinks and alcohol Alcohol can enhance the antihypertensive effect of Bisogamma 10. Pregnancy and breastfeeding If you are pregnant or breastfeeding, or if you think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Use of Bisogamma 10 during pregnancy is only permitted after careful assessment of the benefit-risk ratio by the doctor. In general, beta-receptor blockers reduce blood supply to the placenta and can affect fetal development. Monitoring of placental and uterine blood supply and fetal development is recommended, and alternative treatment should be prescribed if necessary. The newborn should be monitored from birth. Low blood sugar and bradycardia are generally expected in the first 3 days after birth. Breastfeeding It is unknown whether bisoprolol/metabolites are excreted in breast milk. Therefore, breastfeeding is not recommended when taking Bisogamma 10. Driving and using machines: Studies in patients with coronary artery disease have shown that the preparation does not affect the ability to drive. However, due to individual differences in reactions to the drug, the ability to react may be altered to such an extent that driving, operating machinery without safety measures can have negative consequences. This is especially true at the beginning of treatment, when the dose is increased, when the preparation is changed, and when used with alcohol. 3. How to take Bisogamma 10 Always take this medicine exactly as your doctor or pharmacist has told you. If you are unsure, ask your doctor or pharmacist. Treatment is usually started with low doses and then the doses are increased. In any case, the dosage is selected individually, specifically according to the pulse rate and therapeutic effect. Recommended dosage: High blood pressure (hypertension): Unless otherwise prescribed, the recommended dose is 1 film-coated tablet of Bisogamma 10 (corresponding to 5 mg bisoprolol fumarate per day) once a day. For mildly elevated blood pressure (diastolic blood pressure up to 105 mmHg), treatment with 2.5 mg bisoprolol fumarate once a day may be sufficient. If the effect is insufficient, the dose may be increased to 2 film-coated tablets of Bisogamma 10 once a day (corresponding to 10 mg bisoprolol fumarate per day). Further dose increase is permitted in exceptional cases. The maximum dose is 20 mg once a day. Coronary heart disease (angina pectoris) Unless otherwise prescribed, the recommended dose is 1 film-coated tablet of Bisogamma 10 once a day (corresponding to 5 mg bisoprolol fumarate per day). If the effect is insufficient, the dose may be increased to 2 film-coated tablets of Bisogamma 10 once a day (corresponding to 10 mg bisoprolol fumarate per day). Further dose increase is permitted in exceptional cases. The maximum recommended dose is 20 mg once a day. Dosage in liver and kidney failure: In patients with mild to moderate liver and kidney failure, dose adjustment is usually not necessary. In patients with severe kidney failure (creatinine clearance less than 20 ml/min) and patients with severe liver damage, the daily dose should not exceed 10 mg bisoprolol fumarate. Use in elderly patients: Dose adjustment is not necessary for elderly patients. Use in children and adolescents: Bisogamma 10 is not indicated for children as its safety and efficacy have not been studied. Method and duration of administration The film-coated tablets should be taken whole with sufficient liquid in the morning before breakfast, during or after breakfast. The tablet can be divided into equal doses. Instructions for dividing the tablet To divide the tablet exactly in half, place the tablet with the score line facing upwards on a smooth, hard surface (table or similar), and press down simultaneously on both sides of the score line with your index fingers. This will allow you to divide the tablet into equal parts. Duration of use is not limited in time. It depends on the nature and severity of the disease. The dose of Bisogamma 10 cannot be changed without a doctor's recommendation. Furthermore, treatment with Bisogamma 10 should not be interrupted or prematurely discontinued without a doctor's recommendation. Treatment with Bisogamma 10 requires regular medical monitoring. The duration of treatment is determined by the treating physician. Consult your doctor or pharmacist if you think that the effect of Bisogamma 10 is too strong or too weak. If you take more Bisogamma 10 than you should If there is a suspicion of overdose with Bisogamma 10, contact a doctor immediately. They will decide on the necessary measures depending on the severity of the overdose. The most common signs associated with overdose of Bisogamma 10 are slow heart rate (bradycardia), bronchospasm, sharp drop in blood pressure, heart muscle weakness (heart failure), and low blood sugar (hypoglycemia). In case of overdose, treatment with Bisogamma 10 should only be discontinued after consultation with your treating physician. If you forget to take Bisogamma 10: Do not take a double dose to make up for a missed dose. Continue taking the medicine the next morning at the usual dose. If you stop taking Bisogamma 10: Do not interrupt or stop treatment with Bisogamma 10 without prior consultation with your doctor. Especially in patients with impaired blood circulation in the coronary arteries (coronary heart disease: angina pectoris) (coronary insufficiency), treatment with Bisogamma 10 should not be stopped abruptly, but with gradual reduction (e.g., halving the dose at weekly intervals), as abrupt discontinuation of the preparation can lead to worsening of the patient's condition. If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 4. Possible side effects Like all medicines, this medicine may cause side effects, although not everybody gets them. The evaluation of side effects is based on their frequency: Common may affect up to 1 in 10 people Uncommon may affect up to 1 in 100 people Rare may affect up to 1 in 1,000 people Very rare may affect up to 1 in 10,000 people Unknown frequency cannot be estimated from the available data If you notice any of the following side effects, stop taking Bisogamma 10 and seek medical attention immediately. Psychiatric disorders: Uncommon: depression, sleep disturbances Rare: nightmares, hallucinations Nervous system disorders: Common: dizziness*, headache* Rare: fainting (syncope) Eye disorders: Rare: reduced tear production (to be considered if the patient wears contact lenses) Very rare: conjunctivitis Ear and labyrinth disorders: Rare: hearing impairment Cardiac disorders: Uncommon: slow heart rate (bradycardia), atrioventricular conduction disorder (AV block), worsening of myocardial insufficiency (heart failure) Cardiovascular disorders: Common: cold or numb sensation in the extremities, Uncommon: low blood pressure (hypotension) Respiratory, thoracic and mediastinal disorders: Uncommon: bronchospasm in patients with a history of bronchial asthma or obstructive pulmonary disease Rare: allergic rhinitis Gastrointestinal disorders: Common: gastrointestinal complaints such as nausea, vomiting, diarrhea, constipation Hepatobiliary disorders: Rare: inflammation of the liver (hepatitis) Skin and subcutaneous tissue disorders: Rare: allergic reactions (itching, transient redness (erythema), rash). Very rare: hair loss, beta-adrenoceptor blockers can cause or worsen psoriasis or cause a psoriasis-like rash. Musculoskeletal and connective tissue disorders: Uncommon: muscle weakness, muscle cramps Reproductive system and breast disorders: Rare: decreased potency General disorders and administration site conditions Common: fatigue* Uncommon: weakness (asthenia) Investigations Rare: increased triglyceride levels, increased liver enzymes (ALAT, ASAT) * The above-mentioned symptoms usually occur at the beginning of treatment. They appear in mild forms and disappear on their own within 1-2 weeks of starting treatment. Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine. 5. How to store Bisogamma 10 Store the medicine in a place protected from light and out of reach of children. Do not use the medicine after the "expiry date" indicated on the outer cardboard box and blister. The expiry date refers to the last day of that month. Store below 25°C Store Bisogamma® 10 in its original packaging. Do not dispose of medicines down the drain or with household waste. Ask your pharmacist how to dispose of medicines you no longer use. 6. Contents of the pack and other information What Bisogamma 10 contains: The active substance is bisoprolol fumarate. 1 film-coated tablet contains 10 mg bisoprolol fumarate. Other ingredients are: crospovidone, corn starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate (Ph. Eur.), macrogol (6000), polysorbate 20, titanium dioxide, calcium carbonate, talc, iron (III)-hydroxide-oxide x H 2 O, hypromellose The appearance of Bisogamma 10 and contents of the pack: Bisogamma 10 are round, pale yellow, film-coated tablets with a score line. Blister packs of 30, 50 and 100 film-coated tablets. Hospital packs of 300 film-coated tablets. Not all pack sizes may be available for sale. Prescription status: Pharmaceutical product group II, dispensed by prescription №3 See also: Bisogamma - Bisogamma 5mg 30 tablets
